Wrist OsteoarthritisPROOFNCT04260165
Proximal Row Carpectomy vs Four-corner Fusion for Osteoarthritis of the Wrist
A study testing Proximal Row Carpectomy and Four-corner fusion in people with Wrist Osteoarthritis and Scapholunate Advanced Collapse, run by Töölö Hospital at 5 sites in Finland.
Trial summary
Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wrist Osteoarthritis, Scapholunate Advanced Collapse
- What is being tested?
- Proximal Row Carpectomy and Four-corner fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 5 sitesFinland
- Study dates
- 1 Oct 2020to 31 Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SLAC/SNAC II-III
- Age 18 - 75
- Symptom duration > 3 months
- American Society of Anaesthesiologists physical status (ASA) I-II
Who cannot join
- Patient eligible for SL reconstruction or scaphoid
- Ulnocarpal/pancarpal arthritis
- Lunate fossa, proximal lunate arthrosis or both
- Age <18 or >75 years
- Rheumatoid arthritis
- Heavy smoking (> 20 cigarettes per day)
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- Condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids)
- Alcohol or drug abuse
- Neurological condition affecting upper limb function
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jorma Ryhänen, adj. prof. contact
5 sites in 1 country
Finland5 sites, 5 recruiting
- Recruiting
Töölö Hospital (Helsinki University Hospital)
Helsinki
Samuli Aspinen, M.D., Ph.D., +358406360546, samuli.aspinen@hus.fi
Jorma Ryhänen, adj. prof, jorma.ryhanen@hus.fi
- Not yet recruiting
Central Hospital of Central Finland
Jyväskylä
Teemu Karjalainen, MD, PhD
- Not yet recruiting
Kymenlaakso Central Hospital
Kotka
Kaj Zilliacus, MD
- Not yet recruiting
Tampere University Hospital
Tampere
Veera Pikkarainen, MD
- Not yet recruiting
Turku University Hospital
Turku
Hanna-Stiina Taskinen, MD, PhD
About this study
Official title: A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) for Osteoarthritis of the Wrist
Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting.
Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded.
Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.
- Being tested
- Proximal Row Carpectomy, Four-corner fusion
- Keywords
- Wrist Osteoarthritis, Scapholunate Advanced Collapse, Scaphoid Non-union Advanced Collapse, Wrist arthrodesis, Proximal Row Carpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Row CarpectomyProcedure or surgery
Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
Four-corner fusionProcedure or surgery
Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate
| Study group | Role | What they receive |
|---|---|---|
| Proximal Row Carpectomy | Experimental | Not described Receives: Procedure: Proximal Row Carpectomy |
| Four-corner fusion | Active comparator | Not described Receives: Procedure: Four-corner fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Rated Wrist Evaluation
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
Measured: 12 months
Secondary outcomes (8)
Quick-Disabilities of the Arm, Shoulder and Hand
The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)
Measured: 12 months
Pain (Visual Analogue Scale)
The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain)
Measured: 12 months
Global improvement
Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better
Measured: 12 months
Grip strength
Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side
Measured: 12 months
Wrist range of motion (ROM)
Wrist ROM is measured on both wrists with a handheld goniometer in degrees.
Measured: 12 months
Complications
Incidence of complications (i.e. non-union, fracture, reoperation, infection, hematoma, iatrogenic tendon/nerve/arterial injury, complex regional pain syndrome) is recorded and compared between study groups.
Measured: 12 months
Patient-rated Quality of Life (EQ-5D)
Measured: 12 months
Cost-effectiveness
Quality-adjusted life years/months measured as a change in EQ-5D
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wrist OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital, Turku University Hospital, Jyväskylä Central Hospital, Kymenlaakso Central Hospital Kotka Finland
- Responsible party
- Principal investigator, Samuli Aspinen, Töölö Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260165
- Sponsor's protocol ID
- HUS/3487/2019
- Acronym
- PROOF
- Status last verified
- Jan 2021
- First submitted
- 5 Feb 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alanen M, Stjernberg-Salmela S, Waris E, Karjalainen T, Miettunen J, Ryhanen J, Aspinen S. Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial. Trials. 2023 Aug 7;24(1):499. doi: 10.1186/s13063-023-07544-1.
PubMed 37550711
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded Randomized Controlled Multicenter Trial Comparing Proximal ROw carpectOmy and Four-corner Fusion (PROOF) for Osteoarthritis of the Wrist
- ClinicalTrials.gov ID
- NCT04260165
- Acronym / sponsor ID
- PROOF / HUS/3487/2019
- Keywords
- Wrist Osteoarthritis, Scapholunate Advanced Collapse, Scaphoid Non-union Advanced Collapse, Wrist arthrodesis, Proximal Row Carpectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital, Turku University Hospital, Jyväskylä Central Hospital, Kymenlaakso Central Hospital Kotka Finland
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study purpose is to compare the outcome after proximal row carpectomy (PRC) vs four-corner fusion (FCA) for SLAC/SNAC II-III type osteoarthritis (OA) in a double-blinded randomized controlled study setting.
Patients with radiologically and clinically confirmed OA are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either PRC or FCA. The study will be patient and assessor blinded.
Baseline data is collected preoperatively and is followed by a follow-up visits at 2 and 6 weeks, 3, 6, 12 months, and 5, 10 years after the intervention. Unveiling of the allocation is at 12 months post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal Row Carpectomy | Experimental | Procedure: Proximal Row Carpectomy |
| Four-corner fusion | Active comparator | Procedure: Four-corner fusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- SLAC/SNAC II-III
- Age 18 - 75
- Symptom duration > 3 months
- American Society of Anaesthesiologists physical status (ASA) I-II
Key exclusion criteria (9 listed)
- Patient eligible for SL reconstruction or scaphoid
- Ulnocarpal/pancarpal arthritis
- Lunate fossa, proximal lunate arthrosis or both
- Age <18 or >75 years
- Rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal Row CarpectomyExcision of the proximal carpal row - the scaphoid, lunate and triquetrum | Procedure or surgery | Proximal Row Carpectomy |
| Four-corner fusionScaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate | Procedure or surgery | Four-corner fusion |
Primary outcome
Patient-Rated Wrist Evaluation
Time frame: 12 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
8 secondary outcomes
Quick-Disabilities of the Arm, Shoulder and Hand
Time frame: 12 months
Pain (Visual Analogue Scale)
Time frame: 12 months
Global improvement
Time frame: 12 months
Grip strength
Time frame: 12 months
Wrist range of motion (ROM)
Time frame: 12 months
Complications
Time frame: 12 months
Patient-rated Quality of Life (EQ-5D)
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 37550711Alanen M, Stjernberg-Salmela S, Waris E, Karjalainen T, Miettunen J, Ryhanen J, Aspinen S. Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial. Trials. 2023 Aug 7;24(1):499. doi: 10.1186/s13063-023-07544-1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorma Ryhänen, adj. prof. contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal Row Carpectomy and Four-corner fusion in people with Wrist Osteoarthritis and Scapholunate Advanced Collapse, run by Töölö Hospital at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuli Aspinen, MD, PhD (+358406360546, samuli.aspinen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Rated Wrist Evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04260165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.